Labeling Regulatory Affairs Manager: FDA Compliance
Supernus Pharmaceuticals
Supernus Pharmaceuticals is seeking a Manager of Regulatory Affairs Labeling to lead the development, review, and approval of commercial product labeling and printed component artwork. You will collaborate with Clinical Development, Medical Affairs, Quality, and Packaging vendors to ensure labeling compliance with FDA and ICH guidelines. The role requires expertise in labeling content governance, change control, and cross-functional leadership. #J-18808-Ljbffr Supernus Pharmaceuticals
- ...Role SummaryThe Director, Regulatory Affairs Advertising, Promotion & Labelling is responsible for... ...ability to navigate complex compliance requirements.Key... ...activities. Stay abreast of FDA and OPDP/APLB... ...team (including senior management) exhibiting a combination...SuggestedLocal areaFlexible hours
- Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling and promotion strategy, ensuring compliance across the US/UK/EU. You will partner with Commercial, Medical, Legal, and Compliance teams to deliver compliant...Suggested
$110k - $135k
...patient outcomes. Job Summary: The Manager of Regulatory Affairs Labeling is responsible for the development,... ...content is accurate and compliant with FDA regulations and ICH guidelines. The... ...-component artwork for regulatory compliance, readability, accuracy, and alignment...SuggestedWork at officeVisa sponsorship- The Emmes Company, LLC is seeking a Manager, Regulatory Affairs to lead regulatory strategy and biosafety-compliance for diverse clinical programs. This remote US role combines... ...execution, enabling effective dialogue with FDA and other agencies. You will guide submissions...SuggestedRemote job
$218.06k - $327.09k
...people. Role The Senior Regulatory Affairs Director (SRAD) leads the... ...approval with advantageous labeling. Lead the planning and construction... ...interactions (e.g., FDA advisory committee meetings,... ...Proven leadership and program management experience, as well as the...SuggestedHourly payTemporary workWork at officeFlexible hours3 days per week- ...steer US promotional regulatory strategy in a way... ...Regulatory Affairs, you will set the... ...claims early, guide labeling implications, and... ...Your expertise with FDA engagement will help... ...HCP, Consumer, and Managed Markets segments and... ...promotion and compliance come together—pairing...Work at officeFlexible hours3 days per week
- ...AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States... ...into timely approvals and competitive labeling. You will lead cross-functional teams, partner with senior leaders, and manage Health Authority interactions from...
- ...in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy... ...driving rapid approvals and advantageous labeling. You will chair the Global Regulatory Sub-team with regional input, manage regulatory milestones, and mentor RAD/...
$186.23k - $279.35k
...Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role... ...approvals and competitive labeling that make a tangible difference... ...mitigation plans to senior management. Milestone Delivery:... ...activity. Experience with FDA advisory committee or EMA oral...Hourly payTemporary workLocal areaFlexible hours$171.6k - $286k
...seeking an experienced regulatory leader to join our... ...support appropriate labelling based on the available... ...address them. Ensure compliance with applicable regulatory... ...regulatory-affairs experience across pharmaceutical... ...and lifecycle management. Experience leading...Work at officeLocal areaRemote work$171.75k - $286.25k
...The Director, Global Regulatory Strategy- Oncology is... ...regulatory strategy and labeling objectives that are consistent... ...people leadership, manage and develop direct or... ...in Regulatory Affairs within the pharmaceutical... ...Demonstrated experience ensuring compliance with applicable...Work at officeLocal area2 days per week3 days per week- GlaxoSmithKline seeks an experienced Regulatory Affairs Manager (CMC) for mRNA vaccine development, located in the US across multiple sites. You will lead key regulatory CMC activities, shaping strategies and ensuring timely approvals in collaboration with regulatory,...
- Role Senior Director of Regulatory Affairs overseeing global... ...strategies liaise with FDA, EMA, MHRA oversee regulatory... ..., briefing documents, labeling provide leadership... ...direct reports ensure compliance with global regulatory... ...and commercialization manage health authority...
$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory... ...relationship with the FDA, along with being responsible... ...plans, and target labelling to support product... .... You will manage, prepare, co-ordinate... ...submissions for regulatory compliance, in conjunction with...Full timeWork at officeLocal areaRemote workWorldwideNight shift- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure...Remote job
- ...Technology (GDIT) seeks a Quality Assurance Manager to oversee QA engineers and automation testers on a new FDA contract. The role emphasizes stability, reliability... .... You will shape test strategies, ensure regulatory compliance, and manage end-to-end QA activities across...Contract workWork at office
- ...Position Summary The Early Childhood Specialist I provides grants management support and delivers professional customer service for Head... ...coordination with federal staff. Identify performance or compliance concerns and support development of risk mitigation strategies...Contract workWork at officeRemote work
$113.85k - $189.75k
...about GSK and R&D: Our approach to R&D Regulatory Affairs Manager, CMC mRNA Vx Development Products As a... ...regulatory CMC strategies that ensure compliance and timely approvals. We are looking... ...global regulatory requirements including FDA regulations, Good Manufacturing...Work at officeLocal areaRemote work- ...Accountabilities Oversee regulatory project management and operational delivery for development-stage... ...the Infectious Disease Regulatory Affairs Management team through direct and indirect... ...milestones, submissions and compliance activities are planned, forecast, reported...Hourly payTemporary workLocal area3 days per week
$126.25k - $171.58k
...uphold policies that create an inclusive and collaborative work environment. Brief Job Overview The Senior International Regulatory Affairs Manager serves as a critical enabler of regulatory engagement and influence to support the realization of USP’s mission priorities...Full timeWork at officeWorldwide$160k - $218k
...opportunity As Associate Director, Regulatory Affairs, you'll lead global... ...commercialization, and lifecycle management for a therapeutic area. •... ...with regulatory guidance on labeling and promotional materials.... ...preparing high-quality FDA/EMA submission documentation...Work experience placementSummer workLocal area$186.23k - $279.35k
...breakthrough programs, where your regulatory leadership translates... ...As a Director Regualtory Affairs CMC you will shape end-to-end... ...Regulatory Intelligence and Risk Management: Interpret global... ...manufacturing changes and quality compliance and participate in technical...Hourly payFull timeTemporary work3 days per week- GSK seeks an experienced Director of Global Regulatory Strategy to lead regulatory planning for Respiratory, Immunology and Inflammation assets. You will shape development programmes, coordinate with global teams and drive regulatory submissions with health authorities...
- AstraZeneca plc in the United States seeks a Director of Promotional Regulatory Affairs to set the guardrails that allow bold yet compliant brand... ...drive responsible growth. The role demands leadership, deep FDA knowledge, and experience shaping global to US promotional...
- GlaxoSmithKline seeks a Director, Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for oncology assets... ...needed. The role requires extensive experience in Regulatory Affairs, cross-functional collaboration, and global regulatory leadership...
$176.97k - $303.37k
...to the Chief Risk Officer, the Chief Compliance Officer is a senior leadership position... ...direction and oversight of compliance risk management activities across all business lines... ..., and internal controls aligned with regulatory requirements and industry best practices...Full timeWork at officeRemote workFlexible hours- ...Description Job Description The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing... ...and maintenance of product labeling for assigned products. Reporting to... ...discipline. ~ Strong understanding of FDA regulations and guidelines. DESIRED...
- ...motivated and experienced Senior Manager/Manager, Regulatory Affairs (level based on... ...for IND/BLA preparation, labeling, operations, and/or regulatory... ..., and procedures ensuring compliance is maintained with all... ...liaison between company and FDA and other global Regulatory...Work at office
$125.06k - $187.59k
Launch Planning Manager Location: Gaithersburg, MD... ...Brand Directors, Medical Affairs, Market Access, and... ...medical, diagnostics, labeling, market access, marketing... ...dates. Quality, Compliance, and Continuous Improvement... ...with Medical, Legal, Regulatory (MLR) review processes...Temporary workWork at officeFlexible hours3 days per week- ...seeking a Director of Employee Relations & Compliance to design and lead scalable ER and... ...tech to handle investigations, risk, and regulatory obligations across regions. The role emphasizes... ..., Security, and business leaders to manage complex employee matters and drive...
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